Clinical TrialJun 11, 2026, 02:41 AM
Cellectis BALLI-01 Phase 1 shows 100% ORR; NATHALI-01 88% ORR
AI Summary
Cellectis presented final Phase 1 data for lasme-cel (BALLI-01) in relapsed/refractory B-cell acute lymphoblastic leukemia and preliminary data for eti-cel (NATHALI-01) in relapsed/refractory B-cell non-Hodgkin lymphoma at EHA 2026. The BALLI-01 trial achieved a 100% overall response rate and 57% complete remission in the target Phase 2 population, demonstrating a manageable safety profile. The NATHALI-01 study showed an 88% overall response rate and 63% complete response in the optimal dose cohort, with findings suggesting alemtuzumab optimization. Both pivotal Phase 2 trials are open for recruitment, with key data expected in Q4 2026.
Key Highlights
- BALLI-01 Phase 1 achieved 100% overall response rate (7/7) in target Phase 2 population.
- BALLI-01 showed 57% complete remission/CRi (4/7) and 75% minimal residual disease-negative status.
- BALLI-01 safety profile included CRS, ICANS, and IEC-HS all at 4% or less for grade 3 or higher.
- NATHALI-01 preliminary data showed 88% overall response rate and 63% complete response in optimal dose cohort.
- NATHALI-01 patients were heavily pre-treated with a median of 3 prior lines of therapy.
- Pivotal Phase 2 BALLI-01 trial is open for recruitment, with interim analysis expected in Q4 2026.
- NATHALI-01 study is open for recruitment, with full Phase 1 clinical data expected in Q4 2026.
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